In combing through regulations.gov this morning, I found a July 7, 2025 petition (here) submitted by a physician citing concerns about “prematurely expiring drugs.”  His point is that many drugs likely would still meet all of the required specifications outlined in an application well past their labeled expiration dates, which could positively impact drug shortages and save consumers money.  While the petition does not provide a very specific action that it want the FDA to take, it implies that the petitioner would like manufacturers to adhere to and have the FDA enforce Section 2512 of the Consolidated Appropriations Act of 2023.  This section of the Act addresses the issue of using longer expiration dates for products if the data supports the drug product’s quality in an effort to reduce drug shortages.

Section 2512 of the Act, titled EXTENDING EXPIRATION DATES FOR CERTAIN DRUGS (see here and search for section 2512), addresses the issues discussed in the petition.  The petitioner acknowledges that the FDA currently has shelf-life extension programs in place associated with the Department of Defense, and the FDA can and does exercise its regulatory discretion in certain instances of either drug shortages or National Health Emergencies to ensure that there are sufficient quantities of drug products to meet public health needs.

The petitioner states, “In fact, the drug manufacturers have a financial incentive to label medications with short expiration dates in order to force subsequent purchase of additional drugs.  The manufacturer has to only demonstrate full stability by the chosen expiration date, but the pharmaceutical company does not currently have any incentive to perform further annual stability studies that would extend the expiration date.”  The petitioner also states that “[t]he implementation of such a policy would result in savings of millions of dollars.”

While I’m not sure that pharmaceutical companies keep shorter expiration dates for the reason that the petitioner asserts, the general concept of longer expiration dating is a reasonable concept.  However, unexpected things can and do go wrong during storage like, for instance, the nitrosamine impurity issue.  I am trained as a pharmacist and have been involved in the drug industry both from the FDA and the industry sides of the house for over fifty years.  When I first started, many drugs, like ibuprofen, that were rock solid had expiration dates of up to five years.

There are provisions for firms to include additional testing via approved stability protocols in their applications.  Most firms select an initial 24-month stability date for their products but continue to test the products for up to 36 months under the protocols in their application.  Once the first three commercial batches are tested and pass full real-time stability, the firm can, if it chooses, extend the expiration date to comply with the data that supports the longer stability date.  However, in cases where the data just passes or the product shows a greater decline in assay, appearance, or impurities, etc. and there is a greater chance that other batches might fail, firms would be hesitant to make the switch to the longer expiration date for fear of a costly investigation and potential recall if the product did fail one of its specifications.  Also, remember that stability testing at firms is conducted under controlled temperature and humidity, which might not be the case during shipment or storage at home, especially after the original seals on the bottles have been broken and the products are used for extended periods of time.  These variables would likely cause firms to be cautious about extending expiration dates for fear of receiving patient complaints if there were problems found.

There are two sides to the question of extending expiration dating periods.  It is true that having a longer expiration date on a product may help prevent drug shortages, but the flip side to this argument is that recalls could become a more frequent occurrence and damage a firm’s reputation with both the public and the Agency.  The Agency’s reply to this petition will be interesting, especially in light of the statutory provisions outlined in the Consolidated Appropriations Act of 2023.  It will also be interesting to see how industry responds to these provisions.